FDA wants to educate providers and patients on biosimilars as more of the products enter the market, but funding may only be available for a targeted campaign.

Agency officials plan to provide material for webinars and presentations, as well as work with professional societies and other groups to help providers understand the biosimilar concept and the products’ relationship to their reference products, just as is done with small molecule generics, Center for Drug Evaluation and Research Director Janet Woodcock told a Senate panel Sept. 17.

Members of the Senate Health, Education, Labor and Pensions Subcommittee on Primary Health and Retirement Security worried that biosimilar uptake could be hindered without the proper education campaign. Some suggested physicians may be flooded with incorrect information.

Woodcock said FDA’s biosimilar program “didn’t contemplate funding for a large educational campaign to the outside world” and that it is “fully occupied” with existing product development programs.

This may have been a hint that more money would be necessary for a large-scale campaign targeted at providers and patients.

Sen. Bill Cassidy, R-La., said after the hearing that no additional federal funding for such an effort should be needed. He said scientific conferences and other events will include presentations and other information for physicians explaining how biosimilars work.

“The market will take care of those resources,” he said.

So far, FDA has approved one biosimilar product – Sandoz Inc.’s Zarxio (filgrastim-sndz), which references Amgen Inc.’s Neupogen (filgrastim). Zarxio recently entered the market following its approval in March ([A#14150903006]).

However, a court battle involving the product continues ([A#14150910004]).

Four other biosimilar applications have been filed, although their status is unclear ([A#00150727009]).

The agency also is dealing with 57 biosimilar development programs ([A#00150810008]).

If enhanced provider and patient education is judged necessary, additional funding could come from the biosimilar user fee program, which so far has limited resources compared to its sister fees for prescription and generic drugs.

But the mix of reference product and biosimilar sponsors negotiating on behalf of industry may make such a provision difficult to add to the next commitment letter.

Formal BsUFA reauthorization talks are expected to begin in early 2016 Also see "Biosimilar User Fee Negotiations Won't Start Until 2016" - Pink Sheet, 7 September, 2015..

FDA Plans ‘Just-In-Time’ Doctor Information

Biosimilar and reference sponsors as well as other industry stakeholders surely will be pushing either the virtues or problems with biosimilar products to physicians in a number of settings.

But FDA likely is one of the few organizations in position to provide unbiased and unfiltered information on the products.

Woodcock said after the hearing that doctors already are beleaguered with information and FDA will have to target biosimilars material and provide “just-in-time information.”

In the case of Zarxio, which is used in cancer treatment, Woodcock said it will not be necessary to educate all providers about it.

“We can go to professional societies and target appropriately,” she said after the hearing.

FDA also is conducting focus groups to determine the current level of understanding and what people need to know.

Woodcock said during the hearing that the agency likely will have to target physician subspecialties individually.

“We have a menu of educational activities planned out in the next several years,” she said.

Educational activities have not been a priority for the agency so far. Most of FDA's biosimilar efforts have been spent on product development meetings and related activities, followed by policy development, according to a recent workload report ([A#00150914003]).

Don’t Repeat Mistakes, Warren Says

Sen. Elizabeth Warren, D-Mass., told FDA that biosimilars must avoid the perception problems that small molecule generics experienced when the Hatch-Waxman Act opened that market in the 1980s.

Without public and provider confidence, biosimilars might not be able to realize the expected savings to the health care system, based on projected discounts of 15% to 30% less than reference biologics, she said.

Warren said coming up with a plan to deal with public perception of biosimilars is urgent.

“Generics have been on the market for 30 years … and yet even today, this is not a fully open market where physicians will prescribe and where patients have confidence in the drug,” she said.

Indeed, in some cases the generic industry still suffers from a number of perception problems, including accusations about a lack of equivalence Also see "FDA's Woodcock Expresses Concern Not All Generics Are Equivalent, But OGD May Have Solution" - Pink Sheet, 1 November, 2010..

FDA Biosimilar Education Campaign Will Need To Be Targeted

More from United States

More from North America